Impact of Time Interval Between Trauma and Operation on Clinical Outcome in Patients With Delayed Rib Fixation (Nonunion)

NCT06788067 | Active Not Recruiting

• 1 other identifier: 2024-02144; kt25Lardinois
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this monocentric observational study is to evaluate the outcomes of patients who underwent a delayed surgical stabilization of rib fractures/surgical stabilization of rib fracture nonunion (SSRFN) based on the timing of surgery after trauma.

Conditions

Rib Fractures; Nonunion of Fracture

Keywords

Surgical stabilization of rib fractures (SSRF); Delayed SSRF; Nonunion SSRF

Outcome Measures

Primary Outcomes (4)

• Pain status at Follow-up (FU)

  The pain status at the timepoint of the follow-up visit is measured using the numeric rating scale (NRS, scale 0: no pain to 10: worst pain) in different situations (at rest, at movement, and during deep inspiration). The type of pain (local, diffuse, neurogenic) will be also assessed.

  After surgery at follow-up visit (1-8 weeks after recruitment)

• Recommendation of the surgery to another person in a situation like the own

  The patients will be asked if they would recommend the surgery to another person in a situation like the own. The assessment will be performed in two categories: yes/no.

  After surgery at follow-up visit (1-8 weeks after recruitment)

• Pain status at FU compared to before surgery

  The pain status at the timepoint of the follow-up visit compared to the timepoint before surgery in five distinct categories on a Likert-scale (much better, slightly better, no change, slightly worse, much worse).

  After surgery at follow-up visit (1-8 weeks after recruitment)

• Painkiller Use (including nonsteroidal anti-inflammatory drugs and opioids)

  The painkiller use including nonsteroidal anti-inflammatory drugs and opioids is being recorded.

  After surgery at follow-up visit (1-8 weeks after recruitment)

Secondary Outcomes (10)

• Health status

  After surgery at follow-up visit (1-8 weeks after recruitment)

• Resumption of daily/professional activity at FU

  After surgery at follow-up visit (1-8 weeks after recruitment)

• Resumption of daily/professional activity at FU compared to before surgery

  After surgery at follow-up visit (1-8 weeks after recruitment)

• Complications

  Day 30 after surgery

• Correlation between Number of Broken Ribs, Fixed Ribs, and Impact on Patient Outcomes

  After surgery at follow-up visit (1-8 weeks after recruitment)

Other Outcomes (2)

• Satisfaction with the decision for surgery

  After surgery at follow-up visit (1-8 weeks after recruitment)

• Satisfaction with cosmetic results

  After surgery at follow-up visit (1-8 weeks after recruitment)

Study Arms (2)

Delayed SSRF

Patients who underwent surgery between 3 weeks and 3 months after trauma

Nonunion SSRF

Patients who underwent surgery more than 3 months after trauma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 75-80, patients who underwent rib fixation later than 3 weeks after trauma at the Department of Thoracic Surgery of the University Hospital Basel between 2012 and end of June 2024

You may qualify if:

• Patients who signed the study specific consent form
• Patients aged ≥18 years at the time of informed consent
• Patients who provided written informed consent in accordance with ICH-GCP regulations prior to participating any protocol-specific follow-up
• Patients with at least one rib fracture caused by trauma (traffic accident, falls), surgery (cardiac, thoracic, lung transplantation), sports, cough, and cardiopulmonary resuscitation

You may not qualify if:

• Patients who were treated conservatively
• Patients who underwent rib fixation till 3 weeks after trauma
• Patients who underwent SSRF prior to SSRFN
• Patients who are unable to follow the procedures of the study, e. g. have insufficient knowledge of German or French languages, psychological disorders, dementia etc.
• Patients with a pathological rib fracture(s) due to malignancy or radiation
• Participation in any interventional study in our department that might influence any of the outcome parameters
• Patients who underwent an initial surgery of rib fracture prior to development of a rib fracture nonunion

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Thoracic Surgery, University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Rib Fractures; Fractures, Ununited

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Study Officials

• Maria Svec

  Department of Thoracic Surgery, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 22, 2025
• Study Start: January 13, 2025
• Primary Completion: August 4, 2025
• Study Completion: February 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

CH (1)